Warning letter
Brookfield Medical/Surgical Supply, Inc.: warning letter of Jul 5, 2016
FDA warning letter 492682 · New England District Office
Key facts
| Reference number | 492682 |
|---|---|
| Company | Brookfield Medical/Surgical Supply, Inc. |
| Subject | CGMP/Compounded Drugs/Misbranding |
| Issue date | Jul 5, 2016 |
| Posted date | Jul 5, 2016 |
| Issuing office | New England District Office |
| Product type | Drugs |
| CFR sections cited | 211.111, 211.42(c)(10)(v), 201.115, 211.192, 200.10(b), 211.42(c)(10)(iv), 211.56(a), 211.113(b), 211.167(a), 210.1(b) |
| Inspection city | Brookfield |
| Inspection ZIP | 06804 |
| Inspection start date | Mar 30, 2015 |
| Letter on fda.gov | web.archive.org |
At a glance
- 10–99 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: